Tampa, Florida 33606


Purpose:

This is a single-blind, randomized (1:1 allocation), stratified, single-parallel clinical trial at one institution evaluating the use of a preoperative patient education video as an adjunct to preoperative counseling on patient-centered outcomes. The aim of this study is to determine the impact of a preoperative patient educational video as an adjunct to the routine preoperative visit on patients' preparedness for surgery, perception of time spent with their healthcare team, and ultimately their satisfaction after surgery. The aim of this video is not to limit the doctor patient interaction (as all patients will still be granted their pre-allotted 30 minute visit with the physician regardless of their intervention allocation) but rather to augment the visit with additional educational information in an attempt to optimize the visit. Objective: A. Primary Aim(s): • To determine if patients feel more prepared for surgery with addition of preoperative patient education video B. Secondary Aim(s): - To determine if addition of preoperative patient education video correlates with improved patient satisfaction after surgery - To determine if patients' perception of time spent with healthcare team in preparation for surgery increases with addition of patient educational video - To determine if actual patient-physician time spent counseling differs between groups - To determine if patient preparedness is correlated with objective surgical outcomes - To determine if patient preparedness is correlated with patient symptom improvement scores after surgery Hypothesis: The addition of a preoperative patient education video enhances patient preparedness for surgery, increases perception of the amount of time patients spend with healthcare team, and improves patient satisfaction.


Criteria:

Inclusion Criteria: - Women >18 scheduled to undergo either a laparoscopic or robotic-assisted sacrocolpopexy - It is acceptable if concomitant procedures such as suburethral slings or additional vaginal repairs are planned - English speaking - Willing and able to provide written and informed consent Exclusion Criteria: - Women <18 - Not scheduled to undergo either a laparoscopic or robotic-assisted sacrocolpopexy - Non-English speaking - Unable or unwilling to provide written and informed consent


NCT ID:

NCT02076360


Primary Contact:

Principal Investigator
Kristie Greene, MD
University of South Florida

Kristie A Greene, MD
Phone: 312-848-9343
Email: kgreene2@health.usf.edu


Backup Contact:

Email: ObGynClinicalResearch@health.usf.edu
Caroline Young, MSN, ARNP
Phone: 813-259-8685


Location Contact:

Tampa, Florida 33606
United States

Kristie Greene, MD
Email: kgreene2@health.usf.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.